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A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00622635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2011-08-18

Study results available
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Summary

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.

Conditions

Interventions

DRUG

Indacaterol 300 μg

Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).

DRUG

Placebo to indacaterol

Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).

DRUG

Salmeterol 50 μg

Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622635 on ClinicalTrials.gov